Medical Policy

Policy Num:       07.001.016
Policy Name:     STEREOTACTIC, ULTRASOUND GUIDED BREAST BIOPSY (MIBB)
Policy ID:          [07.001.016]  [Ac / L / M+/ P- ]    [0.00.00]


Last Review:      October 24, 2024
Next Review:      October 20, 2025

 

Related Policies:

None

STEREOTACTIC, ULTRASOUND & MRI GUIDED BREAST BIOPSY (MIBB)

Population Reference No.

Population

   Interventions

           Comparators

                        Outcomes

1

Individuals:
  • With a non-palpable lesion(s) on breast study, needing tissue diagnosis
Interventions of interest are:
  • Stereotactic breast biopsy
Comparators of interest are:
  •  open breast biopsy

Relevant outcomes include:

  • Overall quality of life and accurateness of achieving tissue diagnosis

2

Individuals:
  • With a non-palpable lesion(s) on breast study, needing tissue diagnosis

Interventions of interest are:

  • Ultrasound-guided breast biopsy

Comparators of interest are:

  •  open breast biopsy

Relevant outcomes include:

  • Overall quality of life and accurateness of achieving tissue diagnosis

3

Individuals:
  • With a non-palpable lesion(s) on breast study, needing tissue diagnosis

Interventions of interest are:

  • MRI guided breast biopsy

Comparators of interest are:

  •  open breast biopsy

Relevant outcomes include:

  • Overall quality of life and accurateness of achieving tissue diagnosis

4

Individuals:

  • With a palpable lesion(s) on breast study, needing tissue diagnosis

Interventions of interest are:

  • Ultrasound-guided biopsy

Comparators of interest are:

  • palpation guided biopsy

Relevant outcomes include:

  • Overall quality of life and accurateness of achieving tissue diagnosis

5

Individuals:

  • with skin lesion on breast 

Interventions of interest are:

  • skin punch biopsy

Comparators of interest are:

  • other type of biopsy

Relevant outcomes include:

  • Overall quality of life and accurateness of achieving tissue diagnosis

6

Individuals:

  • CNB results are inconclusive or discordant with the imaging findings or a  lesion is in such a location that it is not amenable to CNB 

Interventions of interest are:

  • surgical biopsy

Comparators of interest are:

  • core or fine needle biopsy

Relevant outcomes include:

  • Overall quality of life and accurateness of achieving tissue diagnosis

Summary

Minimally Invasive Breast Biopsy (MIBB) is a breast biopsy that is done with a needle to obtain a diagnosis of a breast abnormality. There are three different types of MIBB.

Breast biopsy methods include core needle biopsy (CNB), fine needle aspiration (FNA), surgical biopsy, and skin punch biopsy. 

Based on the prebiopsy imaging, the radiologist makes an assessment of which approach will yield the highest likelihood of success, while considering patient safety and comfort. The imaging findings are correlated with the clinical exam to determine whether the chosen biopsy target(s) account for the clinical abnormality. The requirements of subsequent therapy and/or clinical trial (eg, marker clip placement, tissue banking) are additional factors that are included in biopsy planning.

The choice of imaging guidance depends upon the modality on which the lesion is best visualized and whether it is palpable. Patient factors such as tolerance for positioning (eg, prone position is usually needed for stereotactic or magnetic resonance imaging [MRI] guidance) are also considered.

Objective

The objective of this evidence review is to evaluate minimally invasive breast biopsy technique in achieving a tissue diagnosis on a non-palpable breast lesion. BiRad 4 or 5 mammography reading.

Policy Statements

Triple-S will consider for payment Stereotactic-guided non-palpable breast lesions that are seen only on mammography (not well visualized on Ultrasound).

Triple-S will consider for payment MRI- guided non-palpable breast lesions that are seen only on MRI  (not well visualized on Ultrasound or mammography).

Triple-S will consider for payment Ultrasound-guided of palpable or non-palpable high-risk breast lesion(s) or masse(s).

Triple-S considers MIBB  is an invasive procedure, which will limit the payment coverage to those surgeons and radiologists who submit evidence of training and experience as established by the "Board of Regents of the American College of Surgeons "and by the" Board of Chancellors of the American College of  Radiology "in the following document: Physician Qualifications for stereotactic breast biopsy: a revised statement. Bulletin of the American College of Surgeons. Vol. 83, No.5, January 2014, and ACR Practice Guideline for the performance of Stereotactic guided Breast interventional procedure of 1996, revised in 2009.
 

 Indications:

a.    Indications - the main use of this technology is obtaining tissue for diagnosis of non-palpable breast lesions. Within this framework, the main indications are the following:

• non-palpable lesions that are highly suggestive of malignancy
• Indeterminate lesions
• Benign lesions associated with multiple risk factors in the patient
• Lesions with well-defined solid mass characteristics, solid lesions with indistinct or spiculated  margins and micro-calcifications

b.    Limitations - Triple-S will consider for payment the stereotactic breast biopsy when the services are rendered in the following places:

• Hospital (inpatient)
• Hospital (outpatient)
• Ambulatory surgery center
• Office
 

Policy Guidelines

Clinical decision-making

A positive mammography report — All reports with BΙ-RΑDS 0, 4, or 5 need further intervention. In most institutions, the clinician is contacted to convey the need for biopsy, and both the clinician and patient are contacted to convey the need for further imaging.

In addition, a BΙ-RΑDÐ… designation of 4C or 5 indicates that a malignant diagnosis is strongly suspected and that a possible rebiopsy is needed if the pathology tissue sample is initially interpreted as benign.

Billing and documentation guides:

The codes for billing stereotactic guided breast biopsy that includes image-guided breast biopsy, placement of localization devices (pellet, clip) and sample images are:

• 19081-1st lesion  Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet, radioactive seed), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including stereotactic guidance. 
• 19082- additional lesion  Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including stereotactic guidance (List separately in addition to code for primary procedure)

19283 -19284 are used when localization is performed and a device placed (clip, pellet, wire, needle, or radioactive seed-RSL) adjacent to a non palpable breast lesion to mark site for an open breast procedure / percutaneous breast biopsy to be performed during a separate procedure same or other day by a breast surgeon (different setting). Stereotactic guidance.

The codes for Ultrasound-guided breast biopsy, that includes image-guided breast biopsy including placement of localization devices (pellet, clip) are:

• 19083-  Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including ultrasound guidance
• 19084-  Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including ultrasound guidance (List separately in addition to code for primary procedure)

19285-19286 are used when localization is performed and a device placed (clip, pellet, wire, needle, or radioactive seed-RSL) adjacent to a non palpable breast lesion to mark site for an open breast procedure / percutaneous breast biopsy to be performed during a separate procedure same or other day by a breast surgeon (different setting). Ultrasound-guided.

The codes for MRI guided breast biopsy, that includes image-guided breast biopsy including placement of localization devices (pellet, clip) are:

19287 - 19288  are used when localization is performed and a device placed (clip, pellet, wire, needle, or radioactive seed-RSL) adjacent to a non palpable breast lesion to mark site for an open breast procedure / percutaneous breast biopsy to be performed during a separate procedure same or other day by breast surgeon (different setting). MRI guided.

These codes only apply when the service is provided after the placement of the device in different meetings with different providers.

 The code 99070 will be billed for the payment of the service by the facility.  Supplies and materials (except spectacles), provided by the physician or other qualified health care professional over and above those usually included with the office visit or other services rendered (list drugs, trays, supplies, or materials provided)

Based on the currently available evidence, radioactive seed localization of nonpalpable breast lesions is likely to produce outcomes equivalent to wire localization. Therefore, the "least costly alternative" provision of the medically necessary definition may apply (see Benefit Application section).

When breast localization device(s) such as radioactive seeds are placed without biopsy, the procedure would be reported with codes 19281-19288, depending on the type of imaging guidance used and whether the lesion is an initial or subsequent lesion. If the breast localization device(s) is placed at the time of image-guided biopsy, it would be reported with codes 19081-19086, depending on the type of imaging guidance used and whether the lesion is an initial or subsequent lesion. The seeds might be reported with the tissue marker HCPCS code A4648.

Documentation requirements:


a. The documentation in the medical record must be consistent with the "Indications" section of this policy. 


b. When the procedure involves more than one lesion in the same breast, the documentation in the file of the physician must show that the lesions are separate and independent of each other and that each biopsy is medically necessary.

Reasons for denying payment cover:

1. Triple-S, Inc. will consider the following claims as not covered:

• Invoices that do not include CPT and ICD-10 codes
• Invoices of codes included in another (eg 19081 vs 19283) by the same physician in the same location.

2. Triple-S, Inc. understands that all information on diagnosis and procedures included in the invoices must be documented in the medical record. If it is determined subsequently that such documentation does not exist, the overpayment will be recovered
 

Benefit Application

BlueCard/National Account Issues

 

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Radioactive seed localization of nonpalpable breast lesions is likely to produce outcomes equivalent to wire localization but may be costlier. Some plans may use a definition of "medical necessity" that states that a medically necessary service must not be more costly than an alternative service or sequence of services that are at least as likely to produce equivalent health outcomes. In these cases, when it is determined that a strategy using radioactive seed localization is more costly than one using wire localization (as determined by plan pricing, provider charges, and/or other mechanisms), then radioactive seed localization may be considered not medically necessary for localization of nonpalpable breast lesions.

For contracts that do not use this definition of medical necessity, benefit or contract language describing the "least costly alternative" may also be applicable for this choice of treatment. In addition, other contract provisions including contract language concerning the use of out-of-network providers and services may be applied. For example, if the alternative therapy (eg, wire localization) is available in-network but radioactive seed localization is not, radioactive seed localization would not be considered an in-network benefit.

Background

Practice guidelines recommend biopsy for all BI-RADS 4 and 5 lesions. If there are clinical factors (eg, age, comorbidities, etc) for which the patient, in consultation with her/his clinician, chooses to defer biopsy, the reasoning should be documented in the medical record.

Palpable breast lesions — For palpable breast lesions, diagnostic breast imaging is still mandatory and should always precede biopsy. Correlation between imaging and the palpable area of concern is essential and involves radio-opaque skin markers on mammography and patient and radiologist input during imaging for breast ultrasound.

In contemporary practice, most palpable lesions deemed suspicious on diagnostic imaging are biopsied with image guidance. However, biopsy under palpation guidance without imaging can be performed at select sites where the necessary proceduralist and on-site cytopathologist expertise are available. 

Lesions seen on mammography — For mammographic abnormalities, core needle biopsy (CNB) under imaging guidance has largely replaced surgical excision following wire localization as the former is better tolerated and less invasive. For lesions detected on screening mammography, diagnostic mammography is performed to better characterize the lesion and define the biopsy approach. Breast US is also performed to determine whether the mammographic abnormality is seen and amenable to US-guided CNB. If the abnormality on mammography consists of microcalcifications alone without a mass, US may not be required, as stereotactic or tomosynthesis CNB, which like mammography involves x-ray imaging, would be the standard biopsy approach.

Lesions seen on ultrasound — US is used to evaluate mass abnormalities detected on palpation, mammography, or magnetic resonance imaging (MRI). In addition, some abnormalities are detected primarily on US as this modality is used as an adjunct to mammography for breast cancer screening. Biopsy using US guidance is preferred over other imaging modalities when feasible as the procedure is well tolerated by the patient, enables real-time visualization of where the lesion is sampled and allows for placement of a marker clip for post-biopsy management.

Lesions seen on magnetic resonance imaging — Breast lesions are detected on MRI in patients undergoing cancer screening or those with breast cancer undergoing treatment planning or follow-up. If a lesion occult on mammography is detected on MRI, the patient will undergo US to determine whether the lesion is amenable to US-guided CNB . US-guided CNB is usually preferred over a magnetic resonance (MR)-guided biopsy as the latter procedure is not available at some sites, is more resource intensive and involves longer patient table times. Lesions not visible on US are biopsied under MR guidance at sites with the necessary resources and expertise. It is important to verify on follow-up MRI that the lesion sampled under US or MRI guidance does indeed correlate with the original MRI finding

 CNB is the preferred initial approach for most scenarios. With lesions likely to be cellular and malignant (eg, invasive ductal carcinoma), FNA with intraprocedural cytopathology is an alternative as it may expedite patient management. Surgical biopsy is not used as the initial biopsy method unless percutaneous needle biopsy is not feasible or available, but it may be required to further investigate discordant or inconclusive results of percutaneous biopsies.

Core needle biopsy — CNB is preferred as the initial biopsy procedure as it is minimally invasive and still likely to acquire sufficient tissue to adequately sample the intended target.

A small skin incision is made through which the core biopsy needle (typically 9 to 14 gauge [approximately 2.1 mm outer diameter]) is introduced. The shortest path to the lesion is typically chosen. Patient safety (eg, staying parallel to the chest wall to avoid pneumothorax) is another important factor in the approach. CNB is typically performed under local anesthesia.

In a meta-analysis, CNB under ultrasound (US) or stereotactic guidance demonstrated a sensitivity of 87 percent (95% CI 84 to 88 percent) and specificity of 98 percent (95% CI 96 to 99 percent) [15].

Careful radiologic-pathologic correlation is required to ensure the pathologic diagnoses are concordant with the imaging findings. When targeting calcifications, specimen radiography should be performed. 

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Diagnostic biopsy of breast lesions seen on imaging
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Vacuum assistance — Vacuum-assisted directional biopsy (VAB) is an option for CNB under any imaging guidance.

Use of a VAB device increases the volume of tissue that can be obtained quickly and may decrease the false-negative rate for tumor detection. In a series of 942 consecutive breast CNBs performed at one institution (342 without image guidance, 241 with US guidance, and 369 using a stereotactic VAB) [30], the false-negative rate with 11 gauge stereotactic VAB was 3 percent, compared with 13 percent for non-image-guided and 5 percent for US-guided procedures [30]. Others report false negative rates as low as 0.45 percent with 11 gauge VAB.

Vacuum-assisted devices are typically 9 gauge and are heavier in weight than non-vacuum-assisted biopsy needles. 7, 8, 9, and 10 gauge VAB devices are also commercially available. Using a larger-diameter device will yield a larger volume of tissue, and fewer cores are needed for a diagnostic sample. For example, the 8 gauge VAB device yields approximately 245 to 310 mg of tissue per core compared with the 11 gauge device, which yields 83 to 116 mg of tissue per core.

VAB enables collection of multiple samples with a single pass of the biopsy device. The built-in collection chamber and tubing enables both vacuum-assisted sampling and saline lavage of the biopsy site. However, the weight of these devices makes them more suited for stereotactic or tomosynthesis CNB, where the device can be mounted on a base, than for US-guided CNB that involves free-hand manipulation of the biopsy needle. Vacuum assistance is also suited for MRI-guided biopsies, where target lesion visualization is transient during uptake and washout of intravenous contrast, making timeliness of sampling a higher priority.

For US-guided procedures, spring-loaded CNB through a coaxial sheath is a lower-cost alternative to VAB devices. Spring-loaded devices are typically 12 to 14 gauge, self-contained, and light in weight, allowing for ease of handling with one hand while the other holds the US probe for real-time visualization. Multiple core samples of different regions of the target can be obtained under real-time imaging guidance with the coaxial sheath.

The number of samples taken will vary depending on the size of target and differential considerations. At our institution, we generally take four to six samples for US core biopsies and 12 samples on average for stereotactic and MRI biopsies. As with any percutaneous biopsy, the radiologist should assess for radiologic-pathologic concordance of biopsy results and recommend additional sampling or surgical excision as appropriate. In the setting of uncertain lesions, more cores may be necessary.

Care should be taken to avoid over-sampling. The purpose of the biopsy is to establish a diagnosis in the setting of suspected cancer, and not to resect the entire lesion. The latter approach may disrupt margin assessment for future surgical management.

Clip placement — A marker clip is placed in the sampled region of the breast at the time of a CNB to mark the biopsy site for subsequent management and follow-up. Different shapes or types of clips may be used if more than one lesion is biopsied in order to differentiate the various sites. This becomes especially important in the event that surgery is required for only one of the lesions. 

Clip placement following sample acquisition with CNB is useful in several settings:

●To document that the lesion has been sampled and that it correlates with the lesion originally detected on mammography or MRI [36]. If a subsequent excisional surgical biopsy is necessary, the clip serves as a guide for lesion localization.

 

●To mark the biopsy site of small lesions that might be completely removed during CNB or are no longer visible following CNB.

 

●To mark the tumor site of patients in whom neoadjuvant therapy is planned. If complete clinical and radiographic response is observed, the clip serves to guide subsequent surgery.

Clinical decision-making

A positive mammography report — All reports with BΙ-RΑDS 0, 4, or 5 need further intervention. In most institutions, the clinician is contacted to convey the need for biopsy, and both the clinician and patient are contacted to convey the need for further imaging.

In addition, a BΙ-RΑDÐ… designation of 4C or 5 indicates that a malignant diagnosis is strongly suspected and that a possible rebiopsy is needed if the pathology tissue sample is initially interpreted as benign.

A negative mammography report — If there is a clinical suspicion for malignancy, a negative mаmmоgram should not deter further evaluation (). The false-negative rate of screening mаmmоgrаphу has been reported between 10 to 30 percent, with the false-negative rate being highest in those with markedly dense breast tissue [63-65].

Up to 15 percent of cancers detected on clinical breast examination are not visible on diagnostic mаmmоgraphу [64,66,68]. The addition of ultrasound decreases the false-negative rate but still does not exclude the presence of breast cancer [68]. In the setting of a negative imaging evaluation (mаmmоgrарhу plus ultrasound), the chance of malignancy ranges between 0 and 3 percent [115,116]. The evaluation of a palpable breast mass is reviewed elsewhere. (See "Diagnostic evaluation of suspected breast cancer", section on 'Palpable breast mass'.)

Regulatory Status

In 2011, the BrachySciences Radioactive Seed Localization Needle with AnchorSeed™ (Biocompatibles) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process (K111979). This device is indicated for the localization of suspicious tissues (nonpalpable lesions) for excision with the use of radioactive seeds.

In 2012, the Best® Localization Needle with I-125 Seed (Best Medical International) was cleared for marketing by the FDA through the 510(k) process (K122704). This device is indicated for breast localization under the direct supervision of a qualified physician. It comprises an I-125 seed and an 18-gauge 5 cm to 20cm needle.

These devices are not always used for radioactive seed localization. Radioactive seeds approved for another indication (ie, off-label) may also be implanted with an 18-gauge needle. These seeds were initially approved for permanent implantation (ie, brachytherapy) in select localized tumors such as prostate cancer. These seeds use I-125 beads (activity from 0.1 to 1.0 mCi) encapsulated in a titanium tube. An example is the International Isotopes I3RAD I-125 Seed, which, in 1999, was cleared for marketing by the FDA through the 510(k) process (K992963). FDA product code: KXK.

List of some of the vendors of Breast Biopsy Systems Devices on the market:

USSC Puerto Rico, INC/TYCO Healthcare: ABBI Breast Biopsy System

Becton Dickinson and Co.; BD EleVation Breast Biopsy System, FINESSE Breast Biopsy System

Hologic Inc.: Affirm Prone Breast Biopsy System, Eviva Breast Biopsy System

Devicor Medical Products, Inc., part of Leica Biosystems MAMMOTOME Breast Biopsy System

 

Rationale

Population Reference No. 1  to 6 Policy Statement

 

For individuals who have a nonpalpable breast lesion who are undergoing a procedure that requires lesion localization who receive RSL, the evidence includes RCTs and systematic reviews. The relevant outcomes are other test performance measures, resource utilization, and treatment-related morbidity. Four RCTs have compared RSL with WL, and overall, they have reported similar outcomes (eg, rates of successful excision, the rate of positive margins) with both techniques.

Systematic reviews have also found that outcomes with localization methods are similar. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcomes

Population Reference No. 1 Policy Statement

       Stereotactic imaging — For mammographic abnormalities not well visualized on US, stereotactic CNB is performed. The patient is upright or prone during the procedure, depending on the machine, and the biopsy needle is positioned under x-ray guidance. Breast compression during the procedure is required.

While the majority of mammographic lesions can be biopsied using the stereotactic technique, some lesions (eg, lesions close to the nipple or chest wall, very faint calcifications) are not amenable to this approach. This technique is also not appropriate to biopsy women with a small breast or those unable to tolerate breast compression for the duration of the procedure.

Population Reference No. 1 Policy Statement [ x ] MedicallyNecessary [ ] Investigational

Population Reference No. 2 Policy Statement

Ultrasound imaging— US-guided CNB is usually better tolerated than stereotactic or MRI-guided biopsies as the patient is lying supine during the procedure and does not require breast compression. However, the use of US guidance requires that the lesion is well visualized with US and that there is confidence that the US finding correlates with the target lesion detected on palpation, mammography, or MRI.

Population Reference No. 2 Policy Statement [ x ] MedicallyNecessary [ ] Investigational

Population Reference No. 3 Policy Statement

Magnetic resonance imaging — Some patients will have nonpalpable lesions only seen on MRI. Magnetic resonance (MR)-guided biopsy may not be available at every site, but each facility performing breast MRI should have a service available to refer a patient for an MR-guided biopsy .

MR-guided biopsy is performed with the patient prone and with the breast under compression. Intravenous gadolinium is administered to visualize the abnormality. The procedure involves longer table times than biopsies performed under US, stereotactic, or tomosynthesis guidance. Once adequate needle placement is confirmed, CNB samples are acquired with an MR-safe vacuum-assisted biopsy device (VAB).

A single-center series of 557 MR-guided CNBs demonstrated a sensitivity of 80 percent (95% CI 72 to 86 percent) and specificity of 92 percent (95% CI 90 to 93 percent).

MR-guided wire localization and surgical excision may be indicated if a suspicious lesion is not accessible to MR-guided VAB or if the results are discordant. Some discordant cases will be found to represent false negatives of MR-guided biopsy

 

Population Reference No. 3 Policy Statement [ x ] MedicallyNecessary [ ] Investigational

Population Reference No. 4 Policy Statement

         Palpable breast lesions — For palpable breast lesions, diagnostic breast imaging is still mandatory and should always precede biopsy. Correlation between imaging and the palpable area of concern is essential and involves radio-opaque skin markers on mammography and patient and radiologist input during imaging for breast ultrasound.

In contemporary practice, most palpable lesions deemed suspicious on diagnostic imaging are biopsied with image guidance. However, biopsy under palpation guidance without imaging can be performed at select sites where the necessary proceduralist and on-site cytopathologist expertise are available.

Population Reference No. 4 Policy Statement [ x ] MedicallyNecessary [ ] Investigational

 

Population Reference No. 5 Policy Statement

Skin punch biopsy — A small skin biopsy using a punch biopsy device can differentiate between benign and malignant skin changes. Punch biopsy may be needed if there is concern for Paget disease, skin involvement with invasive breast cancer, inflammatory breast cancer, or skin recurrence of breast cancer.

Population Reference No. 5  Policy Statement [ x ] MedicallyNecessary [ ] Investigational

Population Reference No. 6 Policy Statement

    Surgical biopsy — Surgical biopsy is not the initial method unless needle biopsy is not technically feasible. Surgical biopsy more often serves as the secondary method when CNB results are inconclusive or discordant with the imaging findings. Surgical biopsy is performed in fewer than 10 percent of cases. Surgical biopsy can remove the entire lesion (excisional biopsy) or only a portion of it (incisional biopsy). Whether to perform an incisional or excisional biopsy depends upon the indications for the biopsy:

●Incisional biopsy is used to confirm a diagnosis when a biopsy is nondiagnostic and the mass is large. The intent is to try to reduce the tumor with neoadjuvant therapy.

 

●Excisional biopsy is used in cases where the lesion is in such a location that it is not amenable to CNB or where the result of a CNB is atypical or nondiagnostic/indeterminate, is discordant with imaging results, or yields benign but high-risk lesions. High-risk lesions of the breast are discussed in another dedicated topic. 

 

In addition, a surgical biopsy may also be required when:

●Cysts do not completely resolve after aspiration, indicating that there may be a residual mass. Such lesions should undergo evaluation with a CNB if technically feasible or a surgical excision. However, excisional biopsy of simple cysts, clustered microcysts, or cysts with thin septa is not necessary.

 

●Size increase of a mass or suspicious changes are seen on follow-up imaging after a CNB with benign results. 

 

Excisional biopsy — The goal of an excisional biopsy is to obtain a histologic diagnosis. To perform complete excision of lesions likely to be cancer, or to excise CNB-proven cancers, is technically not a biopsy, but rather a partial mastectomy. Indications for and techniques of partial mastectomy are discussed in another dedicated topic.

Nonpalpable lesions requiring surgical excision can be localized using a wire or another device under mammographic, US, or MR guidance. A clip placed at the time of CNB will aid in wire localization of the biopsy area at the time of surgery. Alternative, more modern techniques for localization include the use of magnetized seeds or clips with a radiofrequency emitter [58]. Localization techniques are discussed in another topic.

Excisional biopsies can generate scar tissue inside the breast that may prompt future diagnostic evaluation if prior mammograms are not available for comparison.

Population Reference No. 6 Policy Statement [ x ] MedicallyNecessary [ ] Investigational

Supplemental Information

Practice Guidelines and Position Statements

N/A

Medicare National Coverage

The coverage of percutaneous image-guided breast biopsy has long been determined at the local level by Medicare contractors. On December 7, 1999, CMS

issued a national coverage decision memorandum for percutaneous image-guided breast biopsy, which can be found at www.cms.hhs.gov/coverage/8b3-h.asp.

The decision provided coverage for percutaneous image-guidance breast biopsy using stereotactic or ultrasound systems for lesions that are (1) nonpalpable

and (2) BIRADS III, IV, or V. Image-guidance systems included directional, vacuum-assisted breast biopsy, automated surgical biopsy, and core needle biopsy.

For palpable lesions, discretion regarding coverage was left to individual carriers.

References

  1. Meyer JE, Smith DN, DiPiro PJ et al. Stereotactic breast biopsy of clustered microcalcifications with a directional, vacuum-assisted device. Radiology 1997; 204(2):575-6.
  2. Nisbet AP, Borthwick-Clark A, Scott N. 11-gauge vacuum-assisted directional biopsy of breast calcifications, using upright stereotactic guidance. Eur J Radiol 2000; 36(3):144-6.
  3. Jackman RJ, Burbank F, Parker SH et al. Atypical ductal hyperplasia diagnosed at stereotactic breast biopsy: improved reliability with 14-gauge, directional, vacuum-assisted biopsy. Radiology 1997;204(2):485-8.
  4. Darling ML, Smith DN, Lester SC et al. Atypical ductal hyperplasia and ductal carcinoma in situ as revealed by large-core needle breast biopsy: results of surgical excision. AJR Am J Roentgenol 2000;175(5):1341-6.
  5. Adrales G, Turk P, Wallace T et al. Is surgical excision necessary for atypical ductal hyperplasia of the breast diagnosed by Mammotome? Am J Surg 2000;180(4):313-5.
  6. Simon JR, Kalbhen CL, Cooper RA et al. Accuracy and complication rates of US-guided vacuum-assisted core breast biopsy: initial results. Radiology 2000; 215(3):694-7.
  7. Burbank F. Stereotactic breast biopsy: comparison of 14- and 11-gauge Mammotome probe performance and complication rates. Am Surg 1997; 63(11):988-95.
  8. Liberman L, Hann LE, Dershaw DD et al. Mammographic findings after stereotactic 14-gauge vacuum biopsy. Radiology 1997; 203(2):343-7.
  9. Lamm RL, Jackman RJ. Mammographic abnormalities caused by percutaneous stereotactic biopsy of histologically benign lesions evident on follow-up mammograms. AJR Am J Roentgenol 2000;174(3):753-6.
  10. CPT Changes, An Insider’s View;2014:28-35
  11. Physician Qualifications for stereotactic breast biopsy: a revised statement.  Bulletin of the American College of Surgeons.  Vol. 83, No.5, January 2014
  12. ACR Practice Guideline for the performance of Stereotactic guided Breast interventional procedure of 1996, revised en 2009.
  13. Radiology Today/Vol.15 No.8 P.10 Coding for percutaneous breast procedure, August 2014
  14. UpToDate Breast biopsy, Authors: Bonnie N Joe, MD, PhD Laura J Esserman, MD, MBA Section Editor: Anees B Chagpar, MD, MSc, MA, MPH, MBA, FACS, FRCS(C) Deputy Editor: Wenliang Chen, MD, PhD Contributor Disclosures All topics are updated as new evidence becomes available and our peer review process is complete. Literature review current through: Aug 2020. | This topic last updated: May 16, 2019.
  15. UpToDate 
    Authors:
    Priscilla J Slanetz, MD, MPH, FACR
    Christoph I Lee, MD, MS
    Section Editors:
    Joann G Elmore, MD, MPH
    Gary J Whitman, MD
    Deputy Editor:
    Sara Swenson, MD Contributor Disclosures All topics are updated as new evidence becomes available and our peer review process is complete. Literature review current through: Nov 2024.This topic last updated: Jul 24, 2024.
    https://www.uptodate.com/contents/breast-imaging-for-cancer-screening-mammography-and-ultrasonography?source=history_widget#H3531439430

Codes

Codes
Number
Description

CPT

11102

Tangential biopsy of skin (eg, shave, scoop, saucerize, curette); single lesion    

 

11103

Tangential biopsy of skin (eg, shave, scoop, saucerize, curette); each separate/additional lesion (List separately in addition to code for primary procedure)    

 

11104

Punch biopsy of skin (including simple closure, when performed); single lesion    

 

11105

Punch biopsy of skin (including simple closure, when performed); each separate/additional lesion (List separately in addition to code for primary procedure)    

 

11106

Incisional biopsy of skin (eg, wedge) (including simple closure, when performed); single lesion    

 

11107

Incisional biopsy of skin (eg, wedge) (including simple closure, when performed); each separate/additional lesion (List separately in addition to code for primary procedure)    

 

19081

Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including stereotactic guidance
 

19082

each additional lesion, including stereotactic guidance (List separately in addition to code for primary procedure)
 

19083

Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including ultrasound guidance    
 

19084

Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including ultrasound guidance (List separately in addition to code for primary procedure)
 

19085

Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; first lesion, including magnetic resonance guidance    
 

19086

Biopsy, breast, with placement of breast localization device(s) (eg, clip, metallic pellet), when performed, and imaging of the biopsy specimen, when performed, percutaneous; each additional lesion, including magnetic resonance guidance (List separately in addition to code for primary procedure)    
 

19101

Biopsy of breast; open, incisional  

 

19283

Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including stereotactic guidance    
 

19284

Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including stereotactic guidance (List separately in addition to code for primary procedure)    
 

19285

Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including ultrasound guidance

 

19286

Placement of breast localization device(s) (eg, clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including ultrasound guidance (List separately in addition to code for primary procedure)    
 

19287

Placement of breast localization device(s) (eg clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; first lesion, including magnetic resonance guidance    
 

19288

Placement of breast localization device(s) (eg clip, metallic pellet, wire/needle, radioactive seeds), percutaneous; each additional lesion, including magnetic resonance guidance (List separately in addition to code for primary procedure)    

 

99070

Supplies and materials (except spectacles), provided by the physician or other qualified health care professional over and above those usually included with the office visit or other services rendered (list drugs, trays, supplies, or materials provided)

CPT TERMINATED (EFFECTIVE DATE 9/30/2018)

19100

Biopsy of breast; percutaneous, needle core, not using imaging guidance (separate procedure) 

ICD-10-CM

C50.011

Malignant neoplasm of nipple and areola, right female breast

 

C50.012

Malignant neoplasm of nipple and areola, left female breast

 

C50.021

Malignant neoplasm of nipple and areola, right male breast

 

C50.022

Malignant neoplasm of nipple and areola, left male breast

 

C50.111

Malignant neoplasm of central portion of right female breast

 

C50.112

Malignant neoplasm of central portion of left female breast

 

C50.121

Malignant neoplasm of central portion of right male breast

 

C50.122

Malignant neoplasm of central portion of left male breast

 

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

 

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

 

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

 

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

 

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

 

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

 

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

 

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

 

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

 

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

 

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

 

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

 

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

 

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

 

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

 

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

 

C50.611

Malignant neoplasm of axillary tail of right female breast

 

C50.612

Malignant neoplasm of axillary tail of left female breast

 

C50.621

Malignant neoplasm of axillary tail of right male breast

 

C50.622

Malignant neoplasm of axillary tail of left male breast

 

C50.811

Malignant neoplasm of overlapping sites of right female breast

 

C50.812

Malignant neoplasm of overlapping sites of left female breast

 

C50.821

Malignant neoplasm of overlapping sites of right male breast

 

C50.822

Malignant neoplasm of overlapping sites of left male breast

 

C50.911

Malignant neoplasm of unspecified site of right female breast

 

C50.912

Malignant neoplasm of unspecified site of left female breast

 

C50.921

Malignant neoplasm of unspecified site of right male breast

 

C50.922

Malignant neoplasm of unspecified site of left male breast

 

D05.01

Lobular carcinoma in situ of right breast

 

D05.02

Lobular carcinoma in situ of left breast

 

D05.11

Intraductal carcinoma in situ of right breast

 

D05.12

Intraductal carcinoma in situ of left breast

 

D05.81

Other specified type of carcinoma in situ of right breast

 

D05.82

Other specified type of carcinoma in situ of left breast

 

D05.91

Unspecified type of carcinoma in situ of right breast

 

D05.92

Unspecified type of carcinoma in situ of left breast

 

D24.1

Benign neoplasm of right breast

 

D24.2

Benign neoplasm of left breast

 

D48.61

Neoplasm of uncertain behavior of right breast

 

D48.62

Neoplasm of uncertain behavior of left breast

 

D49.3

Neoplasm of unspecified behavior of breast

 

N63.11

Unspecified lump in the right breast, upper outer quadrant

 

N63.12

Unspecified lump in the right breast, upper inner quadrant

 

N63.13

Unspecified lump in the right breast, lower outer quadrant

 

N63.14

Unspecified lump in the right breast, lower inner quadrant

 

N63.15

Unspecified lump in the right breast, overlapping quadrants

 

N63.21

Unspecified lump in the left breast, upper outer quadrant

 

N63.22

Unspecified lump in the left breast, upper inner quadrant

 

N63.23

Unspecified lump in the left breast, lower outer quadrant

 

N63.24

Unspecified lump in the left breast, lower inner quadrant

 

N63.25

Unspecified lump in the left breast, overlapping quadrants

 

N63.31

Unspecified lump in axillary tail of the right breast

 

N63.32

Unspecified lump in axillary tail of the left breast

 

N63.41

Unspecified lump in right breast, subareolar

 

N63.42

Unspecified lump in left breast, subareolar

 

N64.51

Induration of breast

 

N64.53

Retraction of nipple

 

N64.89

Other specified disorders of breast

 

R92.0

Mammographic microcalcification found on diagnostic imaging of breast

 

R92.1

Mammographic calcification found on diagnostic imaging of breast

 

R92.2

Inconclusive mammogram

 

R92.8

Other abnormal and inconclusive findings on diagnostic imaging of breast

ICD-10-CM 

(Effective Date 10/05/2020)

N63.15

Unspecified lump in the right breast, overlapping quadrants

N63.25

Unspecified lump in the left breast, overlapping quadrants

 

N60.22

Fibroadenosis of left breast

ICD-10-CM (Termination date 09/30/2017)

N63

Unspecified lump in breast

Applicable Modifiers

Policy History

Date Action Description
10/24/2024 Policy Review Reviwed by the Providers Advisory Committee. No changes on statements.
10/26/2023 Policy Review Reviewed by the Providers Advisory Committee.  No changes
11/09/2022 Annual Review Reviewed by the Providers Advisory Committee.  No changes
11/11/2021 Policy Review Reviewed by the Providers Advisory Committee.  No changes
10/19/2021 Policy Review Added dx N63.15, N63.25 effective 10/05/2020.
11/11/2020 Policy Review Reviewed by the Providers Advisory Committee.  No changes
9/02/2020 Policy Reviewed CPT 19083 and Population References added policies merged- 07.001.016, 06.001.065, MRI guided breast biopsy
7/08/2020 Policy Reviewed ICD 10 N60.22 added
11/14/2019 Annual Policy Review Reviewed by the Providers Advisory Committee. No changes
11/14/ 2018 Policy replaced New format.  Reviewed by the Providers Advisory Committee.  No changes
10/01/2017 Policy reviewed Unchanged policy
11/04/2016 Policy reviewed Unchanged policy
10/06/2015 Policy reviewed Unchanged policy
01/23/2014 Policy reviewed Unchanged policy
10/01/2013 Policy repalced ICD-10 added
08/07/2013 Policy replaced ICD-10 added
02/26/2013 Policy reviewed Unchanged policy
11/22/2011 Policy replaced ICD-10 added
07/15/2009 Policy replaced ICES
05/09/2007 Policy reviewed Unchanged policy
03/18/2005 Policy reviewed Unchanged policy
07/28/1998 Polciy created New policy